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Miles
Km80.5

Director, Biologics Quality Operations

Millennium: The Takeda Oncology Company

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Location: Cambridge, MA Posted Date: 4/23/2013 Position Type: Full time Job Code: 7402BR Required Education: High school or equivalent

Description

POSITION SUMMARY:

Provide leadership and direction to the GMP Quality unit that is responsible for the quality, compliance, and disposition of clinical trial materials. This includes ensuring that all drug substance, drug product, and finished goods are manufactured and tested in accordance with FDA, EMA and ICH requirements as well as company quality standards and procedures.

DUTIES & RESPONSIBILITIES:

- Develop strategy and Provide guidance related to GMP compliance to QA and QC staff and the rest of the development organization. - Oversee product release and stability testing, batch record review and the disposition of all clinical trial materials. - Facilitate the timely resolution of all quality related issues (deviations, investigations, CAPAs, OOS investigations, product complaints) for clinical trial materials. - Provide quality oversight of contract manufacturing and testing organizations. - Manage the vendor and internal audit programs. - Communicate significant internal or external compliance issues effectively to department head and business unit Senior Management in a timely manner. - Develop QA and QC goals that are aligned with business objectives. - Determine QA and QC resource needs and organize the activities of QA and QC to ensure adequate support for all active development programs. - Develop and Oversee strategies to Facilitate the transfer of p
roduct quality knowledge from development into the commercialization phase of the drug product life-cycle. - Provide staff with training and development to assure that personnel have the skills to perform assigned duties and the opportunity to grow within the department. - Coordinate with other Takeda group quality departments to improve efficiencies and effectiveness of procedures and systems. - work towards building positive working relationships with internal customers, contract manufacturing organizations and Takeda colleagues. - perform due diligence assessment of external companies in support of new business development.

Requirements

QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill and/or ability required. Minimum

QUALIFICATIONS:

 Strong leadership, mentoring and staff development skills. Experience with biologics QA and QC  Experience providing QA and QC support for early to late stage development programs.  Experience overseeing contract manufacturing and labeling/packaging operations as well as contract testing laboratories.  Experience working within a global CMC organization a plus. Education and/or Experience (including certificates, licenses, registrations):  BS or equivalent and 12+ years of relevant experience including 5+ years of management experience or Advanced degree and 10+ years of relevant experience including 5+ years of management experience.
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